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FDA Finalizes New Guidance for Animal Food Additive Petitions and GRAS Notice Reviews

On December 10, 2020, the FDA finalized guidance document CVM GFI #262, Pre-Submission Consultation Process for Animal Food Additive Petitions (FAPs) or Generally Recognized as Safe (GRAS) Notices, to facilitate consultations between FDA and stakeholders prior to submitting an animal FAP or GRAS notice for an animal food ingredient. The guidance includes recommendations from the FDA Center for Veterinary Medicine (CVM) on the information that should be included with (1) pre-petition consultations prior to animal FAPs; (2) pre-submission consultations for animal food GRAS notifications; and (3) Food Use Authorization (FUA) requests to use, in human or animal food, products derived from animals that have been administered an investigational substance intended for use in animal food.

The guidance, which was first drafted in February 2020, details non-binding recommendations for submissions to investigational food additive (IFA) files and FDA’s review process for IFA submissions, use of foreign data in submissions, the circumstances under which a stakeholder should submit their study protocols, and how to best communicate with FDA regarding regulatory submissions. The guidance encourages early communications between stakeholders and CVM in the FAP or GRAS notice process and emphasizes that stakeholders should email CVM as questions arise to improve the quality of submissions.

New appropriations in the last year have allowed CVM to improve its capacity for animal food ingredient reviews, and it is working to reorganize the Division of Animal Feeds to expedite reviews and improve the process’s efficiency. This guidance furthers its goals of facilitating better communications with stakeholders to bring safe new animal food ingredients to the market. 

© 2022 Keller and Heckman LLPNational Law Review, Volume X, Number 346
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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